Archive for the ‘MISTAKES & STUFF-UPS’ Category

Colleen Stefanyszyn, of the Newcastle suburb Merewether, vomited faecal material for several days before her death following surgery at Newcastle Private Hospital in December, 2008.

It was “the worst red flag that a surgeon would see”, a medical expert said during a NSW Supreme Court hearing that resulted in negligence findings against her gynaecologist and the hospital, and the possibility of contempt action against the hospital relating to the Supreme Court proceedings.

Mrs Stefanyszyn’s death was preventable, NSW Supreme Court Justice Monika Schmidt found in a decision on Tuesday that was highly critical of the hospital and its breaches of duty of care that contributed to Mrs Stefanyszyn’s death.

Justice Schmidt accepted Newcastle gynaecologist and obstetrician Dr Oliver Brown’s admission that he breached his duty of care to Mrs Stefanyszyn and that it had resulted in her death.

Mrs Stefanyszyn’s death “could have been prevented, had available surgical steps been taken”, Justice Schmidt said.

Mrs Stefanyszyn, 61, had vaginal hysterectomy elective surgery at the hospital on December 1, 2008.

During the operation a loop of suture material “inadvertently looped around Mrs Stefanyszyn’s bowel”, resulting in a blockage, Justice Schmidt said.

She lived for just four days after the surgery, vomiting faecal matter from the third day, starting with a “coffee-coloured fluid” on the night of December 3.

While Dr Brown’s response to Mrs Stefanyszyn’s symptoms until the third day was reasonable, it was the medical experts’ common ground that his approach to her subsequent care “was not only wrong, but inexplicable, given her deteriorating condition” that included continued faecal vomiting, Justice Schmidt found.

“Despite Mrs Stefanyszyn not recovering from the surgery as was expected and her deteriorating condition, the cause of her symptoms was not investigated, the blockage was not identified and surgical steps necessary to remove it were not taken, with her death the result,” Justice Schmidt found.

“The result was that the blockage was not identified or addressed; infection set in; she repeatedly vomited faecal material; she inhaled some of that material with resulting pneumonia; her electrolytic balance became disordered; her oxygen levels deteriorated; and finally, she suffered a fatal cardiac arrest.”

Justice Schmidt was highly critical of the hospital, its breaches of duty to Mrs Stefanyszyn which were “more extensive than it finally admitted”, the failure of its staff to record observations of Mrs Stefanyszyn on the three days before her death, and the hospital’s decision not to call evidence to address issues of its breaches.

Dr Brown’s “failure to give evidence in support of his own case and the hospital’s failure to call evidence in its, is that such evidence would not have assisted their respective cases”, Justice Schmidt found.

The hospital’s failures “did not give rise to a mere possibility of injury, but actually materially contributed to the death which resulted from both its failures and those of Dr Brown”, Justice Schmidt found.

The matter returns to court on Friday where Justice Schmidt will consider whether the hospital should face contempt proceedings over aspects of the court case.

In a notice in the Newcastle Herald on the second anniversary of his wife’s death Mr Stefanyszyn wrote: “I have lost my soul’s companion, a life linked with my own. Day by day I miss you more, as I walk through life alone. Forever Wal.”

Her daughters wrote: “What is home without a mother? All things this world may send, but when we lost our darling mother, we lost our dearest friend. Love Leigh and Megan.”

But surgery also appears to be getting a little safer, with the audit, which covers almost every surgery death in Australia, finding fewer faults with the medical care provided to patients than it has in the past.

Audit chair Guy Maddern said of the deaths where there were concerns, about 5 per cent involved serious adverse events that were likely to have contributed to the person’s death.

In about 8 per cent of cases, the audit found some area of care could have been delivered better.

“These are the sorts of deaths where it was a difficult surgery, and instead of going straight to an operation, maybe additional X-rays and imaging should have been pursued, or maybe the skill set of the team that was operating could have been more appropriate,” he said.

“Sometimes, of course, the result would have been exactly the same.”

Surgical deaths: when things go wrong

Percentage of deaths with issues identified, by specialty

Professor Maddern said some surgeons, particularly in general surgery, orthopaedics, and, to a lesser extent, neurosurgery, still needed to work on deciding not to proceed with surgeries where the risks outweighed the benefits.

“People are thinking a little bit longer and harder about whether an operation is really going to alter the outcome,” he said. “These are the types of cases where you know before you begin that it is not going to end well.”

However, in some areas with many patients with complex conditions, things were just more likely to go wrong.

The report, which includes data from nearly 18,600 deaths over five years, found in 2013 the decision to operate was the most common reason a death was reviewed.

Overall, delays in treatment, linked to issues such as patients needing to be transferred or surgeons delaying the decision to operate, were still the most common problem, and in about 26 per cent of the deaths no surgery was performed.

Between 2009 and 2013, the report shows a decrease in the proportion of patients who died with serious infection causing sepsis from 12 per cent to 9 per cent, while significant post-operative bleeding decreased from 12 per cent to 11 per cent. Serious adverse events halved from 6 per cent of deaths in 2009 to 3 per cent in 2013.

Every public hospital now participates in the audit, along with all private hospitals in every state except NSW. However, Professor Maddern said he was pleased NSW private hospitals had agreed to participate in future.

Doctors are now provided with regular case studies from the audit, in which de-identified information about the death is provided, so they can learn from any mistakes.

“What we are seeing is an overall decrease in deaths associated with surgical care, which may be due to many things, and we think the audit is helping,” he said. “It’s making people think twice.”

Professor Guy Maddern’s tips on protecting yourself in surgery

1. If you are away from a major hospital, get yourself to one. A particular problem, Professor Maddern says, exists when rural patients resist transfers to major hospitals because they don’t want to leave their families.

2. Lose weight and don’t smoke.The proportion of deaths where obesity was a factor increased slightly this year. “An operation done on a thin person relative to a fat person can have a completely different outcome,” Professor Maddern says. This is particularly important for older people, who have the most operations.

3. Go to a hospital that performs a lot of the type of surgery you are going to have, particularly if it is complex. Remember, practice makes perfect.

THE note sent by a doctor to several executives at Johnson & Johnson was blunt: an artificial hip sold by the company was so poorly designed that the company should slow its marketing until it understood why patients were getting hurt.

A faulty hip replacement a doctor removed from a patient.

The doctor, who also worked as a consultant to Johnson & Johnson, wrote the note nearly two years before the company recalled the device in 2010. And it was far from the only early warning those executives got from doctors who were paid consultants. Still, the company’s DePuy orthopedic unit plowed ahead, and those consultants never sounded a public alarm to other doctors, who kept implanting the device.

The memos have recently emerged during the trial of the first of more than 10,000 patient lawsuits brought against Johnson & Johnson over the hip implant device, the Articular Surface Replacement, or A.S.R. The company has insisted that it acted responsibly in determining when to halt its sale. But plaintiffs’ lawyers have offered a portrait of executives who put profits ahead of patients, even scuttling a plan to fix the implant because it cost too much.

It might not be surprising to find that executives acted to protect a company’s bottom line. Still, the Johnson & Johnson episode is also illuminating a broader medical issue: while experts say that doctors have an ethical obligation to warn their peers about bad drugs or medical devices, they often do not do so.

“Questioning the status quo in medicine is not easy,” said Dr. Harlan Krumholz, a professor at Yale School of Medicine.

Physicians may remain silent for a variety of reasons, he and other experts said. They may fear that speaking out could get them sued or believe that a product problem was an anomaly or their fault.

Doctors also have an aversion to reporting. For instance, while the Food and Drug Administration relies on physicians to help monitor product safety by alerting the agency to adverse patient reactions, doctors usually do not make such filings, saying they are too busy for the paperwork.

“The standard in the medical community is not to report,” said Dr. Robert Hauser, a cardiologist who, along with a colleague, warned other doctors in 2005 about a defective heart implant.

There is another reason doctors may choose to remain silent, experts say: their financial ties to a drug or device maker.

For years, such consulting payments have raised concerns about the impact of money on a doctor’s decision about which drugs to prescribe or how to interpret research findings. Money can also shift a physician’s sense of loyalty, said George Loewenstein, a professor at Carnegie Mellon University who has studied medical conflict-of-interest policies. “If someone has been paying you or employing you, it is very difficult to blow the whistle,” said Professor Loewenstein, who teaches economics and psychology. “It offends our sense of loyalty.”

Dr. Krumholz said he also believed that such loyalties were between a doctor and a company’s executives, rather than with a company or its brand. Over time, a physician may come to see his relationships with those officials in terms of friendship, while companies see an influential doctor as an asset who helps develop products and boost sales.

For a consultant, breaking those ties can carry a cost. For example, when Dr. Lawrence D. Dorr, an orthopedic specialist, warned fellow surgeons in an open letter in 2008 that a hip implant made by Zimmer Holdings was flawed, he became the subject of a whisper campaign that questioned his skills as a surgeon.

“The first thing that a company does is to put out a campaign that a surgeon does not know how to operate,” said Dr. Dorr, who was a consultant to Zimmer when he wrote the letter. “It hurt my practice for a year.”

TRADITIONALLY, doctors have brought problems to the attention of colleagues by conducting research and publishing their findings in a medical journal. The advantage of that system helps ensure the credibility of study data and protects a researcher from random attack, said Dr. David Blumenthal, the president of the Commonwealth Fund, a group that studies health policy issues.
Natural Joint Promotes Healthy Joints, Flexibility, and Mobility!

But getting a study published can take a year or two; some Johnson & Johnson consultants did publish studies about the hip’s flaws, but they largely appeared after it had been recalled.

Dr. Blumenthal said there was probably a need for more immediate ways for doctors to share their concerns, like forums supported by professional medical organizations. Another approach would be to have companies hire doctors as consultants whose sole concern was product safety, Professor Loewenstein said.

The results of not speaking out are playing out in a Los Angeles courtroom, where the first Johnson & Johnson hip case is unfolding. In the years before the implant’s recall, a British physician, Dr. Antoni Nargol, and a colleague were among those who tried to alert surgeons to the problem.

But the silence of other doctors apparently gave company executives the upper hand; in meetings with Dr. Nargol, they said that he seemed to be the only doctor having trouble.

Hospitals are death trapsSample pic only.
Many Australians and thousands of Americans are killed every month – and many more are badly hurt or sickened – by carelessness, stupidity, and neglect in the one place where they least expect it.

The hospital.

New government numbers prove that zoo animals get better care than our seniors – because one in seven hospitalized Medicare patients suffer from serious medical mistakes.

These are mistakes that require life-sustaining interventions, or cause permanent harm… and that’s not even the worst part of it. The same study showed that nearly 400 people die every month in Australian and 15,000 every month in the U.S. as a result of those mistakes.

That adds up to nearly 185,000 deaths a year, most of them seniors.

And while I think every one of them should be considered preventable, the government is a more generous critic than I. The U.S. Department of Health and Human Services, which conducted the study, says 44 percent of those mistakes could have been caught and prevented.

Still, that adds up to at least 81,400 unnecessary deaths in a single year, and the biggest reason for them can be summed up in a single word: DRUGS. Medication errors – the wrong drug, or the right drug in the wrong amount – accounted for more than half the deaths in the new study.

Other patients suffered from preventable infections, falls, incorrect procedures, bleeding problems and more. Some suffered from more than one mistake – and one elderly patient hit the opposite of a jackpot: Six errors in one hospital stay.

The only encouraging stat here is the cost of all those mistakes – $4 billion a year. That’s practically pocket change in an era of trillion-dollar stimulus and bailout packages.

The Department of Health and Human Services says fixing the system will require new laws, specialized programs, help from patients, yada yada yada.

Give me a break! Just enforce some real safety standards – and axe any doc who screws up.

And since fatigue accounts for more of these errors than anyone will admit, how about this: Stop letting hospitals force residents to work 30-hour shifts and 80-hour weeks.

Give docs, nurses, surgeons, interns and everyone else the rest they need, and maybe they’ll actually be awake on the job most of the time.